Q&A info

The number of hazard statements on the label is in principle not limited, as they will normally have to reflect all hazard classifications of a substance or mixture. The only exception is for evident duplication or redundancy.

In the EU, only those labels, which comply with the CLP rules, will be accepted. This means that the provisions that are laid down in Title III of the CLP Regulation and the details regulated in its Annexes I – V must be respected. However, many aspects in relation to the arrangement of labelling elements and in relation to supplemental labelling information are at the discretion of the supplier of the hazardous substance or mixture.

Yes, they do. Active substances, plant protection products within the scope of Regulation (EC) No 1107/2009 or biocidal products within the scope of Regulation (EU) 528/2012, which are classified as hazardous, must bear a CLP label including the relevant hazard statements, precautionary statements, signal word and pictograms.

In addition, the label of a hazardous plant protection product must also display the statement EUH401 ("To avoid risks to human health and the environment, comply with the instructions for use"). However, in relation to any other aspects of labelling, the provisions of the respective regulations apply, e.g. for the update of a label of a plant protection or biocidal product, see CLP Articles 15(5) and 30(3). Further information can be found in the Guidance on labelling and packaging in accordance with the CLP Regulation available on the ECHA website at http://echa.europa.eu/guidance-documents/guidance-mainly-for-industry-use

Note that an active substance can also be placed on the market for non-pesticidal or non-biocidal uses. In these cases, the labelling provisions set out in CLP Title III apply in full. This means, for example, that the update of the relevant label has to follow the provisions of CLP Article 30(1) and (2).

CLP Article 25 introduces the concept of "supplemental information", which is intended to incorporate additional labelling information 'over and above' that listed in CLP Article 17 (1) (a) to (g). Any non-EU hazard information included along with the CLP label elements may be considered as supplemental information and placed alongside the CLP labelling elements so long as it does not contradict or cast doubt on the validity of the information required by CLP Article 17 (1) (a) to (g), nor makes it more difficult to identify such information. This can only be determined on a 'case-by-case' basis depending on the information being proposed by the importer. Additional guidance on supplemental labelling information can be found in Section 4.8- 'Supplemental labelling information' of the CLP labelling and packaging guidance available on the ECHA website at http://www.echa.europa.eu/guidance-documents/guidance-on-clp.

The general rules for the application of labels are outlined in CLP Article 31. For the hazard pictograms, as detailed in CLP Article 31 (4), the provisions of Annex I, Section 1.2.1, to CLP and Annex V to CLP shall apply. According to Annex V to CLP, hazard pictograms shall have a black symbol on a white background with a red frame wide enough to be clearly visible. Hazard pictograms shall be in the shape of a square set at a point. Each hazard pictogram shall cover at least one fifteenth of the minimum surface area of the label dedicated to the information required by CLP Article 17 (as defined in Table 1.3 in Section 1.2.1.4 of Annex I, 2nd ATP to CLP). Where a supplier chooses to use a label that is larger than the minimum dimensions for a certain capacity of the package, it is not necessary for the size of the pictogram also to be increased, provided it covers one fifteenth of the relevant minimum dimensions and remains proportional to the size of the packaging. The minimum area of each hazard pictogram shall not be less than 1 cm². Note that the size of the pictogram relates to the dimensions of the pictogram itself, and not to the size of the virtual square where the pictogram is embedded. Further guidance can be found in Section 5.2- 'Size of the label and of the label elements' of the Guidance on labelling and packaging in accordance with the CLP Regulation available on ECHA's website at: http://www.echa.europa.eu/guidance-documents/guidance-on-clp.

The CLP Regulation does not require the labelling of substances or mixtures that are only exported and that, within the EU, are only subject to transport operations. It is necessary to take worker health and safety considerations into account during the production packaging and storage stages, to ensure that these substances and mixtures are handled safely.

However, the PIC Regulation ((EU) 649/2012) concerning the export and import of hazardous chemicals (which implements the Rotterdam Convention within the EU) requires that all exported chemicals are classified, labelled and packaged in accordance with the CLP Regulation, the Plant Protection Products Regulation ((EC) No 1107/20), the Biocidal Products Regulation ((EU) No 528/2012) or any other relevant EU legislation, unless those provisions would conflict with any specific requirements of the receiving countries. Further information can be found in sections 4.1 and 6.10 of the Guidance for implementation of the PIC Regulation.

The labelling and packaging requirements for hazardous transported goods are laid down in the respective transport legislation, based on the UN Model Regulations.

According to the criteria given in section 1.2.1 of Annex II to CLP, the hazard statement applies to 'substances and mixtures which in contact with water or damp air, evolve gases classified for acute toxicity in category 1, 2 or 3 in potentially dangerous amounts, such as aluminium phosphide, phosphorous pentasulphide.' No further criteria or guidance are provided as to when this hazard statement should be assigned and no appropriate test methods are indicated. It is recommended that any amount of acute toxic category 1, 2 or 3 gas emitted triggers the inclusion of EUH029. It is thus also recommended to add this sentence to each substance or mixture that releases a toxic gas when in contact with water.

No. Substances or mixtures under the scope of the CLP Regulation can not be exempted from the classification, labelling and packaging requirements regardless of how low the risk is estimated to be and regardless of the size of the packaging. However, certain derogations apply for labelling of small packagings according to Article 29 of CLP.

Article 18(3) of CLP provides that the identity of all substances in a mixture that contribute to the classification of the mixture in certain hazard classes must be given on the label. A maximum of four chemical names are to be included, unless more are needed to reflect the nature and severity of the hazards.

There are no strict rules on how to decide which substances should take precedence to be named on the label, but the following may help in the selection.

For non-additive health hazards (e.g. germ cell mutagenicity, carcinogenicity, reproductive toxicity, respiratory or skin sensitisation and specific target organ toxicity categories 1 and 2), all ingredients which are present in the mixture above the generic or specific concentration limit should be considered as "primarily responsible for the major health hazards" within the meaning of Article 18(3)(b) CLP and included on the label.

For the additive health hazards mentioned in Article 18 (3)(b) CLP (e.g. acute toxicity, skin corrosion, serious eye damage, specific target organ toxicity category 3 and aspiration hazard), all ingredients which are present in the mixture above the generic or specific concentration limits should be included on the label. However, where there are several ingredients contributing to classification for one hazard endpoint, only the ingredients primarily contributing to the classification, for example, those closest to the GCL or SCL, need to be included on the label, and thus the names of other ingredients with limited contribution to the classification are not required.

In addition, specific labelling rules apply to mixtures containing skin and respiratory sensitisers. See Annex I Table 3.4.6 and Annex II, point 2.8.

No, they are not. Article 33(1) of CLP outlines that when a package consists of an outer and an inner packaging, together with an intermediate packaging, and the outer packaging meets the labelling provisions in accordance with the rules on the transport of dangerous goods, the hazard pictograms required by CLP do not need to appear on the outer packaging.

For the purpose of CLP, transport labelling is considered to include the limited/excepted quantity marks (chapters 3.4 and 3.5 of the UN Model Regulations for the transport of dangerous goods).

This is explained in the Guidance on labelling and packaging in accordance with the CLP Regulation (chapter 5.4) that states that labelling in accordance with CLP is required only when neither:

• 'normal' transport labelling elements, nor
• other transport labelling elements such as the ‘limited/excepted quantity marks', the mark for environmentally hazardous substances or elevated temperature marks are needed on the outer packaging.

This means that limited/excepted quantities are considered as transport labelling and therefore CLP pictograms are not required when those limited/excepted quantity marks are carried on the outer packaging and the pictograms depicting the same hazard do not need to appear twice. CLP labelling may however be used, if desired according to Article 33(1) of CLP.

The precautionary statement P501 with appropriate specification of where to dispose of the content/container (e.g. public waste disposal or recycling facility), in accordance with the applicable regulation, must be included on the label of any substance or mixture supplied to the general public if the substance or mixture is classified in the hazard classes and categories listed under P501 in Table 6.5 of Annex IV to the CLP Regulation.

Suppliers of substances and mixtures classified as hazardous according to CLP must label them in accordance with CLP before placing them on the market. 

A supplier is any manufacturer, importer, downstream user or distributor placing a substance on the market on its own or in a mixture. Import is considered to be placing on the market (Article 2(18) CLP). Therefore, an importer (supplier) importing (placing on the market) substances or mixtures will have to label them according to CLP. Imported substances and mixtures require CLP labelling, even if the importer and the user are the same legal person.

Where importers make use of a distributor, the importers may not pass this labelling duty to their distributor. The substance/mixture being distributed should be correctly labelled by any supplier (including the importer) in the supply chain.
An importer is not required to classify, notify or label its substances/mixtures in accordance with CLP if the following conditions apply (note that they apply cumulatively):

• the substances/mixtures are under customs supervision;
• there is no treatment or processing activity;
• one of the three following (not cumulative) conditions apply: the substances/mixtures are (a) in temporary storage or, (b) in a free zone or free warehouse with a view to re-exportation or, (c) in transit.

In customs terms, transit means both internal and external transit. In case of doubt, it is recommended to contact the customs authorities, to clarify the applicable customs rules established by Regulation (EU) No 952/2013 on the Union Customs Code.

No, it is not. A hazardous chemical product that is subject to labelling and packaging under CLP must not be confused with a food, medicinal or cosmetic product. For example, a prominent picture of a fruit on the label or packaging can create confusion for the consumer and increase attractiveness to children. Other elements, such as the bright colour, the shape and design of the packaging or the consistency of the chemical may also create a resemblance with food products or with toys.

A hazardous chemical product must not attract the curiosity of children, but apart from children, other vulnerable consumer groups also exist and need to be considered. Therefore, the packaging of a hazardous chemical should not be of a shape or design that, for example, a visually impaired person could confuse with food.

E-liquids for electronic cigarettes are regulated by the Tobacco Products Directive (TPD, Directive 2014/40/EU). The TPD requires Member States to ensure that electronic cigarettes and their refill containers are only placed on the market if they comply with the TPD and with all other relevant Union legislation (Article 20(1)), including the obligations under the CLP Regulation.

Under CLP, the classification, labelling and packaging of an e-liquid is the responsibility of the formulators or importers of the liquid. Under TPD, they must also submit a notification to the competent authorities of the Member States of any such products which they intend to place on the market. This notification should include the classification of the mixture in accordance with CLP. 

The TPD sets its own labelling requirements for the unit packets of electronic cigarettes and refill containers (TPD Article 20(4)). In addition, the refill containers must also be labelled and packaged in accordance with CLP if the e-liquid is classified as hazardous. In that case, the unit packet must have a CLP label, with TPD-related information as supplemental. Overlapping information only needs to be indicated once: for example, the list of all ingredients required by TPD vs the list of ingredients contributing to classification under CLP.

It should be noted that the TPD provides that the nicotine content must not exceed 20 mg/ml and only ingredients that do not pose a risk to human health in heated or unheated forms may be used in the nicotine-containing liquid. However, other components of e-liquids have also been identified as hazardous and need to be considered in the classification and labelling of the e-liquid. 

According to TPD, electronic cigarette devices and refill containers have to be child- and tamper-proof, protected against breakage and leakage and have to have a mechanism that ensures refilling without leakage (Article 20(3)g).

A refillable electronic cigarette device that is empty when placed on the market is not subject to the labelling obligations under CLP, as the hazards are dependent on the contents of the refill container.

Under CLP, candles are regarded as mixtures. Therefore, if a candle is classified as hazardous or where CLP Article 25(6) applies, then the candle must be labelled and packaged in accordance with CLP before placing it on the market. 

An open container of glass or aluminium foil or an openwork paper box are not considered as packaging in the context of CLP Article 35. A candle in such a container, must still be supplied in packaging that complies with the CLP requirements, with the label firmly affixed to one or more surfaces of the packaging immediately containing the candle, and positioned horizontally on the side of the packaging, so that it can be easily read. 

For small candles, certain labelling exemptions may apply, in accordance with CLP Article 29. 

Yes, they do. All substances and mixtures that fulfil the criteria for classification as hazardous in accordance with the CLP Regulation are subject to the labelling requirements of CLP. For example, where the ink used in a pen is classified as hazardous, that will lead to labelling obligations. 

Where the ink reservoir is a fixed component of the pen or marker as it is placed on the market, the pen/marker needs to carry the appropriate labelling. If full labelling is not possible, then the exemptions set out in Article 29 and points 1.5.1 and 1.5.2 of Annex I to CLP can be used. 

In the case of empty (blank) pens and re-fillable pens, the pen body does not need to be labelled, as the body of the pen is an article which is not the container of the ink. The hazards depend on the ink used in the replaceable ink cartridge or refill, which need to fulfil the labelling requirements of CLP.

Yes, they can, if duty holders already submitted information based on national requirements benefitting from the transitional period until 1 January 2025 and did not create a UFI when they labelled the mixture.

A duty holder (downstream user/importer) having submitted notifications before the respective compliance dates following the national requirements that by virtue of national law are not in accordance with the Annex VIII requirements, can benefit from the transitional period until 2025 and does not have to affix the UFI before the date when they submit an Annex VIII-compliant notification, at the latest 1 January 2025.

A mixture for which the duty holder benefits from the transitional period until 1 January 2025 at the latest, will still be compliant with the CLP if distributed without a UFI after the date when the duty holder stops benefitting from the transitional period. That is because, pursuant to Article 25(7) of CLP, mixtures only have to be labelled with a UFI “where under Annex VIII the submitter creates a unique formula identifier”. If, before 1 January 2025, the downstream user or importer had not created a UFI at the time of labelling the mixture, the mixture therefore complies with the CLP Regulation even if it is subsequently distributed without a UFI affixed on the label.

Retailers (distributors) who have received a hazardous mixture benefitting from the transitional period, can still place it on the market without a UFI on the label, because the duty holders did not need to create a UFI by then. Note that in cases where distributors’ activities lead to submission obligations according to Article 4(10) of CLP, these submission obligations apply, and the mixture cannot be placed on the market without a UFI on the label (see section 3.1.2 of ECHA’s Annex VIII-guidance).

The downstream user or importer will only have the obligation to create the UFI as of the date when they stop benefitting from the transitional period (A.1.4. of Annex VIII). This may eventually require relabelling the products already in their warehouses and shelves. These operators may decide to add the UFI to existing labels by means of stickers (see Guidance on Labelling and packaging for more information on placement of the UFI on the label). This option is allowed and will avoid the need to re-print the labels and replace them.

Section 3.1 of the Guidance on harmonised information relating to emergency health response explains which activities lead to the obligation to notify and will help a specific operator to identify their duties. This section needs to be read along the Note to the reader at the beginning of the Guidance document itself, stating the dissenting view of few Member States with regards to the interpretation of duty holder under Article 45.

Yes, it may. Non-EU supplier information may be considered as supplemental information in accordance with Article 25(3), and included along with the EU supplier(s) information on the CLP label as long as it does not contradict or cast doubt on the validity of the information required by CLP Article 17 (1) (a) to (g), nor makes it more difficult to identify such information. 

For information on the effects of the UK withdrawal on labelling obligations related to supplier contact details, see Q&A 1726.

No. The reduced labelling allowed for small packaging under Article 29(2) and Annex I, 1.5.2., can only be applied if it is not possible to provide the full label information in one of the ways specified under Art 29(1) and Annex I, 1.5.1., i.e., on an outer packaging, fold-out label, or tie-on tag. Where one of those methods are used, labelling on the immediate/inner packaging can be given in accordance with point 1.5.1 of Annex I. If full label information does not fit the on the outer packaging, fold-out label or tie-on tag, the information can be reduced in accordance with 29(2) and Annex I, 1.5.2. 

If a hazardous substance or mixture is to be placed on the market in a small container without outer packaging, fold-out label or tie-on tag, then the container must bear the full label information, as specified in Article 17 of the CLP Regulation.